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Physical Activity Interventions for Leg Ulcer Patients

NCT02632695 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-09-07

No results posted yet for this study

Summary

The goal of this study is to test FOOTFIT and enhanced FOOTFIT+, home-based mobile health (mHealth) physical activity (PA) interventions for a minimally ambulatory, chronically-ill, population with leg ulcers. A highly sensitive clinically designed Bluetooth® enabled accelerometer and tracking device (BEAT) worn on the foot during a progressive and evidence-based non-exertive leg conditioning activities for lower leg function (CALF) captures minute foot movements and sends the data to a Smartphone. This six-week feasibility study will compare FOOTFIT to FOOTFIT+, with the added connectivity feature, to promote patient-provider communication, evaluate adherence to PA, and assess signals of efficacy on functional outcomes in a very low fitness population.

Conditions

  • Leg Ulcers
  • Venous Ulcers
  • Varicose Ulcers

Interventions

DEVICE

FOOTFIT

Individuals with venous leg ulcers will be instructed on physical activity movements for their lower legs to be performed over six weeks while wearing a foot based activity monitor (accelerometer) that will send them motivational messages and progress reports. For those in the FOOTFIT Plus group, individuals will have the option to communicate with their wound care provider via text messages, emails or phone calls.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Moby Madisetti, MS · Medical University of South Carolina

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02632695 on ClinicalTrials.gov